FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
23:1 REDUCTION ANGLE
K Number: K973800
·
Decision Mar 11, 1998
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
5
Review Days
156
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Basic Information
- Device Name
- 23:1 REDUCTION ANGLE
- K Number
- K973800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Midwest Dental Products Corp.
- Date Received
- October 6, 1997
- Decision Date
- March 11, 1998
- Product Code
- EGS
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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Other Clearances by Midwest Dental Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K964755 | MICROJET CAVITY PREPARATION SYSTEM | Sep 11, 1997 | Substantially Equivalent |
| K962877 | MIDWEST 300 SE | Oct 18, 1996 | Substantially Equivalent |
| K963050 | TRADITION P, PUSH BUTTON HANDPIECE | Oct 11, 1996 | Substantially Equivalent |
| K955655 | MIDWEST ONE | Mar 5, 1996 | Substantially Equivalent |